Tag: European Union

In 1998, the European Union (EU) and the US signed the Mutual Recognition Agreement (MRA) with provisions specifically about current Good Manufacturing Practices (cGMPs) for drugs but were unable to start implementation. Since 2014, both the US and European Medicines Agency (EMA) revived agreement talks concerning the cGMP provisions. Starting in 2012 with the passage[…]

From FierceBiotech: GlaxoSmithKline CEO Andrew Witty fears that if the European Medicines Agency (EMA) is moved from London, it will cause a tremendous disruption for the UK’s pharma and biotech industry. Experts worry about the possibility of regulatory upheaval if Brexit happens. The fate of the EMA is in the air. Brexit is currently in[…]

The Pharmaceutical industry is gradually coming into compliance with new regulatory requirements including the Falsified Medicines Directive (FMD) for Britain and the Drug Supply Chain Security Act (DSCSA) for the US. An important deadline coming up in November 2017 mandates that manufacturers must include product identifiers, serial numbers, lot numbers, and expiration dates in their[…]

Now that the UK has voted to leave the European Union (EU), there are many questions being asked, Tracy Staton of FirePharma pointed out. The UK had been home to the EU’s European Medicines Agency (EMA) for most of their participation in the union, but that is no more with Brexit. The UK’s life sciences[…]

As the votes were being tallied, the entire world had its eye on the UK. The implications of “Brexit” reverberated around the world as it waited with baited breath. In a 52-48 majority, the UK decided to exit the European Union (EU) after close to 50 years. The actual implementation of Brexit will not be[…]